The paragraph is from a conference call discussing Amgen's strong financial performance in the first quarter of 2025. The call, facilitated by Julianne, is led by Bob Bradway after an introduction by Justin Claeys. It highlights a 9% year-over-year revenue growth driven by a 14% increase in volume, attributed to high demand for Amgen's innovative medicines. Fourteen products saw double-digit sales growth across various medical areas, with the biosimilars portfolio contributing over $700 million in revenue, a 35% increase. Additionally, Amgen achieved multiple positive Phase III clinical trial results, initiated four new studies, and launched three new products or indications, demonstrating the company's robust portfolio and execution.

The paragraph outlines the key drivers of growth in various medical areas for the company. In general medicine, significant growth potential exists with multiple products addressing large, underserved patient populations, such as heart disease treatments like Repatha and an advancing clinical program for residual heart disease risk. In bone health, the company leads globally, particularly with EVENITY, which benefits postmenopausal women by building bone and reducing fracture risk. The company is also advancing obesity treatments, notably with MariTide. In rare diseases, the company highlights the early growth stages of treatments like TEPEZZA, KRYSTEXXA, UPLIZNA, and TAVNEOS, with UPLIZNA showing promise as a B-cell depleting therapy and receiving recent FDA approval for treating IgG4-related disease. The company is also pursuing extended applications for UPLIZNA in other B-cell-mediated diseases. In inflammation, they focus on innovation for difficult-to-treat diseases, featuring Test Spire with its unique TSLP-targeting mechanism.

The company is experiencing strong momentum in severe asthma treatments and has made progress in chronic rhinosinusitis and COPD studies. In oncology, its bispecific T cell engager platform is advancing, with BLINCYTO moving to frontline treatment and blinatumomab receiving FDA breakthrough designation. Promising interim data from a Phase III study in small cell lung cancer will be presented at ASCO. The Phase III study on advanced prostate cancer patients is progressing well. Their biosimilars portfolio contributes significantly to growth, with new U.S. product launches in progress. Despite uncertainty around tariffs and taxes, the company has demonstrated adaptability and agility, having invested nearly $5 billion in U.S. capital projects since the 2017 tax reform.

The paragraph discusses Amgen's recent achievements and future outlook. It highlights nearly $2 billion in expansions in Ohio and North Carolina, and the company's focus on meeting growing patient demand amid a volatile environment. Amgen is advancing Phase III studies, launching new products, and maintaining innovation and growth. The financial results for the quarter show a 9% year-over-year revenue increase and 14% volume growth, driven by strong sales in general medicine, rare disease, inflammation, oncology, and biosimilars. The paragraph emphasizes the dedication of Amgen's global workforce to serving patients and indicates strong performance and execution across the enterprise.

The paragraph highlights the company's recent progress, including positive Phase III trial results, the initiation of new studies, and product launches. It addresses efforts in general medicine, particularly for heart disease, with Repatha and a new cardiovascular program. In bone health, Amgen leads with EVENITY for postmenopausal women. The company is advancing obesity treatment with MariTide. In rare diseases, key products like TEPEZZA, KRYSTEXXA, UPLIZNA, and TAVNEOS show growth potential. UPLIZNA is notably approved for NMOSD and IgG4-related disease, with further FDA filings for generalized myasthenia gravis. The company prioritizes innovation in hard-to-treat inflammatory diseases.

The paragraph discusses the advancements and potential of Test Spire, a therapy targeting TSLP, in treating severe asthma and chronic rhinosinusitis with nasal polyps. It highlights the initiation of pivotal Phase III studies in COPD and developments in oncology, including BLINCYTO's growth and blinatumomab's breakthrough therapy designation. The paragraph also mentions the promising results of Delta in small cell lung cancer and the enrollment progress of Xaluritamig in prostate cancer studies. It emphasizes the company's strong biosimilars portfolio and its strategic approach to launches amid uncertainties related to tariffs and taxes, asserting its adaptability and focus on long-term growth.

The paragraph highlights Amgen's significant investments in U.S. manufacturing and expansion efforts, with $5 billion invested since the 2017 tax reform and an additional $2 billion announced for projects in Ohio and North Carolina. The company emphasizes its adaptability to changes in taxes or tariffs and celebrates strong financial performance and future growth prospects. Amgen is launching new products, advancing clinical trials, and focusing on patient demand and innovation. With nearly 28,000 employees dedicated to its mission, Amgen remains well-positioned for long-term growth. Murdo Gordon further notes the company's strong momentum in 2025, with an 11% year-over-year increase in global product sales and a 27% increase in Repatha sales, showcasing the company's robust product portfolio and execution.

The paragraph highlights the significant growth and strategic efforts of Repatha and EVENITY. Repatha, a treatment for lowering LDL and cholesterol, experienced a 26% sales increase in the U.S. in the first quarter, driven by expanded access and direct-to-consumer initiatives. Its global growth remains strong despite competition. EVENITY, which helps reduce fracture risk in postmenopausal women by building new bone, saw a 29% year-over-year sales increase to $442 million. However, a large treatment gap exists, with over 90% of high-risk patients not receiving proper therapy. Sales in the U.S. grew by 36% as efforts concentrated on increasing brand awareness and prescription volume.

In the first quarter, Prolia sales increased by 10% year-over-year, with a 13% rise in volume, generating nearly $1.1 billion in sales. The rare disease portfolio grew by 3% to $1 billion, despite TEPEZZA and KRYSTEXXA sales being affected by changes in U.S. wholesaler inventory levels. TEPEZZA, beneficial for thyroid eye disease (TED) patients, is targeting a U.S. patient base of about 100,000 with enhanced engagement efforts. Medical feedback, particularly from endocrinologists, is positive, with improved patient access now at over 85% of medical plans without clinical activity score requirements. Internationally, TEPEZZA achieved approval and strong uptake in Japan and is preparing for its EU launch following a positive committee opinion. UPLIZNA sales rose by 14% to $91 million, driven by growth in treating neuromyelitis optica spectrum disorder.

In April, UPLIZNA became the first approved therapy in the U.S. for treating adults with IgG4-related disease, with the first patient treated shortly after approval and Amgen leveraging its rheumatology experience to promote diagnosis and treatment. TEZSPIRE, for severe uncontrolled asthma, saw a 65% year-over-year sales increase with growing adoption by pulmonologists and a significant opportunity to treat 2.5 million global patients. Amgen's oncology portfolio, including drugs like BLINCYTO and IMDELLTRA, grew 10% to over $2 billion in quarterly sales, driven by their bispecific T cell engager platform and positioning BLINCYTO as a standard care for certain leukemia patients. Blood cycle sales increased 52% to $370 million due to broad prescribing patterns.

The paragraph discusses the success of IMDELLTRA, a treatment for extensive stage small cell lung cancer, which achieved $81 million in sales in its first quarter, highlighting its broad adoption in various healthcare settings and positive clinical data showing superior overall survival compared to standard chemotherapy. The global expansion is marked by its launch in Japan. Additionally, the paragraph highlights strong growth in the biosimilar portfolio, with $735 million in sales, including $99 million for the PAVBLU biosimilar, supported by positive feedback from Retina Specialists and the acquisition of a permanent reimbursement Q code. Successful U.S. launches of WEZLANA and BEKEMV biosimilars are also noted, expected to contribute to continued growth and returns in the biosimilar segment.

The paragraph discusses the strong start to 2025 for a company's portfolio, highlighting R&D achievements and regulatory approvals in the first quarter. Notably, the FDA approved UPLIZNA for IgG4-related disease, marking progress in B cell-mediated disease research. Positive Phase III study data for drugs like rocatinlimab, UPLIZNA, and IMDELLTRA was reported, alongside the initiation of Phase III trials for MariTide and TEZSPIRE. Specifically, MariTide, an investigational obesity treatment, began two Phase III trials targeting different adult populations. These studies aim to evaluate the drug's safety, efficacy, and tolerability, with future trials planned for obesity-related conditions.

The paragraph discusses the promising results of MariTide, a drug for chronic weight management, which demonstrated sustained weight loss and improved cardiometabolic parameters over 52 weeks in a Phase II study. Notably, dose escalation improved tolerability, particularly in reducing nausea and vomiting. These findings are informing Phase III studies currently enrolling participants. Key data from ongoing studies are anticipated in the second half of 2025. Beyond MariTide, there's also anticipation for data from the Repatha Vesalius Phase III primary prevention study later this year. MariTide is highlighted as a potential advance for treating obesity and related conditions due to its effective dosing and therapeutic impacts.

The paragraph discusses the positive impacts of Repatha for secondary prevention of cardiovascular events and highlights Olpasiran, a promising RNA medicine for reducing cardiovascular risk in patients with elevated Lp(a). The OCEAN(a) Phase III trial of Olpasiran is progressing well. Additionally, the paragraph highlights UPLIZNA's expanding role in treating rare inflammatory diseases. The FDA approved UPLIZNA for immunoglobulin G4-related disease and it shows promise in generalized myasthenia gravis, based on 52-week Phase III MINT study results. UPLIZNA offers a simplified treatment regimen and reduces steroid dependence, positioning it as a potential new standard of care.

The paragraph discusses Amgen's recent advancements in various medical fields. It highlights the FDA's acceptance of the UPLIZNA MINT Phase III data for generalized myasthenia gravis with a PDUFA date set for December 14, 2025, and its recent approval for IgG4-related disease, emphasizing Amgen's role in developing treatments targeting CD19 positive B cells. It also mentions ongoing Phase III studies of TEZSPIRE, in partnership with AstraZeneca, for chronic obstructive pulmonary disease (COPD) and a regulatory submission for chronic rhinosinusitis with nasal polyps, with a PDUFA date on October 19, 2025. Additionally, it covers the successful results from Phase III studies in the rocatinlimab ROCKET program for atopic dermatitis and the positive interim results from the IMDELLTRA study in oncology, showing a significant survival benefit in the DeLLphi-304 Phase III trial.

The paragraph discusses the promising results for IMDELLTRA in a Phase III trial for small cell lung cancer, which showed significant survival benefits compared to standard chemotherapy. Encouraged by the findings, researchers anticipate sharing detailed results at the ASCO meeting in June and are exploring IMDELLTRA in other trials, including a new Phase III study (DeLLphi-312) for first-line treatment. Additionally, efforts continue to advance other cancer therapies, such as a subcutaneous formulation of the BiTE medicine BLINCYTO, which recently received Breakthrough Therapy Designation from the FDA, and Xaluritamig, a STEAP1 CD3 bispecific T cell engager, in Phase III trials for prostate cancer.

The paragraph highlights Amgen's ongoing efforts in cancer treatment and financial performance. It discusses the exploration of Xaluritamig in prostate cancer trials, and advancements in their bispecific T cell engager platform with treatments like IMDELLTRA, BLINCYTO, and Xaluritamig. The company is also progressing their monoclonal antibody bemarituzumab for gastric cancer, expecting Phase III data soon. Additionally, Amgen is developing biosimilars for OPDIVO, KEYTRUDA, and OCREVUS. Financially, Amgen reported a strong first-quarter performance with $8.1 billion in revenues, a 9% increase from the previous year, driven by growth in key brands. However, they experienced a 6% decrease in net selling prices and a rise in operating expenses due to investments in their late-stage pipeline.

In the first quarter, the company reported a non-GAAP operating margin of 45.7%, surpassing previous forecasts partly due to delayed R&D spending. The integration of Horizon is progressing well, with $500 million in cost synergies expected by year-end. Debt has been reduced by $10.8 billion since the Horizon acquisition, leading to lower interest expenses. The tax rate decreased to 14.6% due to a change in earnings mix. The company generated $1 billion in free cash flow, with $400 million spent on capital expenditures at manufacturing sites. The 2025 capital expenditure outlook remains at $2.3 billion, supporting products and innovation, including MariTide. The company is leveraging AI to enhance various operations and returned capital to shareholders via dividends, which increased by 6% from the previous year.

The paragraph discusses the company's financial outlook for 2025, including reaffirmed revenue guidance between $34.3 billion and $35.7 billion and non-GAAP earnings per share between $20 and $21.20. This guidance accounts for implemented tariffs but not potential future tariffs. Key updates include an expected 20% increase in non-GAAP R&D expenses to support late-stage projects like MariTide and Olpasiran, and anticipated non-GAAP OI&E of $2.3 billion. The non-GAAP tax rate is projected to be between 14.5% and 16%. U.S. sales of WEZLANA will fluctuate with no expected sales in Q2 following high Q1 orders. Other unchanged outlooks include an expected $1.4 billion in other revenue, a 46% operating margin, share repurchases capped at $500 million, and free cash flow performance similar to 2023. Factors affecting free cash flow include changes in tax payments and capital expenditures, with specific impacts in Q2 2025. The text also highlights the focus on U.S. manufacturing investments due to tax and tariff interests.

The paragraph discusses Amgen's manufacturing and investment strategy in the United States, highlighting increased investments in North Carolina and Ohio due to favorable tax policies like the 2017 Tax Cuts and Jobs Act. Amgen is focused on driving innovation, execution excellence, and sustained growth. The financial update concludes, and the floor is opened for questions. Terence Flynn from Morgan Stanley asks about expectations for Phase II data regarding MariTide to be presented at the ADA, seeking key messages and learnings.

In the paragraph, Terence asks James Bradner about the potential control arm in a planned cardiovascular outcomes trial (CVOT) for the drug MariTide. James Bradner responds by highlighting the positive findings from the Phase II chronic weight management study, including sustained weight loss and good tolerability over 52 weeks, as well as favorable effects on cardiometabolic parameters like A1C. He mentions that these results will be discussed in more detail at an upcoming ADA meeting, alongside new mechanistic data recently published in Nature Metabolism. While Bradner refrains from sharing specifics about the CVOT study, he notes Amgen's progress into Phase III trials, which they're expanding to include studies on various conditions like ASCVD, heart failure, chronic kidney disease, and obstructive sleep apnea. An IR call is planned to discuss the ADA session findings further.

The paragraph discusses the commercial strategy for UPLIZNA, a recently approved therapy for IgG4-related disease and myasthenia gravis. UPLIZNA is the first approved treatment for IgG4, with a newly introduced diagnostic code as of October 2023. The disease is mainly managed by rheumatologists, but gastroenterologists and neurologists may also be involved. Amgen, leveraging its extensive experience in inflammation and autoimmune diseases, has deployed a field force to engage with relevant physicians. There are approximately 20,000 IgG4 patients in the U.S., and the company is eager to impact this patient population positively with UPLIZNA. For generalized myasthenia gravis (GMG), Amgen sees an opportunity to enter a competitive market with UPLIZNA, which has a unique mechanism different from existing drugs.

The paragraph discusses the optimistic outlook for a new medical treatment for IgG4-related disease and generalized myasthenia gravis (GMG). James Bradner mentions the potential of their medicine to become a new standard of care for IgG4-related disease due to an 87% reduction in disease-specific flare activity. He also highlights the strong efficacy of their treatment, UPLIZNA, for GMG demonstrated by the Phase III MINT trial, which improved daily living scores in patients with different subpopulations. UPLIZNA is administered every six months, aligning with patients' lifestyles while targeting the disease's core biology by addressing pathologic autoantibodies. The conversation then shifts to Robert Bradway inviting the next question from Michael Yee about the obesity program's narratives concerning its tolerability and titration.

In the paragraph, Robert Bradway and Murdo Gordon discuss their confidence in the competitive tolerability and strong efficacy of their treatment, based on Phase II and pharmacokinetic studies. They believe their Phase III clinical study will demonstrate competitive results for patients with and without type 2 diabetes. While acknowledging the potential market impact of oral medications, they note that oral treatments have not yet achieved the same level of weight loss as their treatment, MariTide. They have accounted for an oral market segment but remain confident in their product’s position.

The paragraph discusses MariTide's potential competitive advantage due to its less frequent dosing compared to weekly GLP-1s, and the pursuit of both oral and non-oral product mechanisms by the company. The conversation then shifts to Repatha, noting its strong market performance despite competition from Novartis' Leqvio. While acknowledging competition, the speaker asserts Repatha's superior profile in the PCSK9 category, highlighting its ability to significantly lower LDL cholesterol and reduce cardiovascular events. Ongoing trials aim to demonstrate Repatha's effectiveness in further minimizing cardiovascular risk, especially in high-risk patients.

The paragraph discusses the growth and accessibility of Repatha therapy, highlighting Amgen's efforts to improve access and affordability for patients. It notes that 50% of commercially insured U.S. patients no longer need prior authorization for Repatha. Amgen is promoting Repatha through primary care and direct-to-consumer advertising, anticipating continued growth. The conversation then shifts to PAVBLU and its reception by the retina specialist community. Amgen is satisfied with their biosimilar portfolio and is working on contracts with larger retina specialist groups, expecting positive developments in the year ahead.

The article discusses a conference call featuring Amgen executives and analysts. After a brief mention of Amgen's charitable contributions, the conversation moves to questions from analysts. Chris Schott from JPMorgan asks about the payer environment for incretins and recent changes announced by CVS. Murdo Gordon from Amgen responds, emphasizing their commitment to making obesity medications accessible and understanding recent decisions by PBMs. Another analyst, Yaron Werber from TD Cowen, asks about the MariTide obesity study, specifically, data timelines and the possibility of switch studies for dosing strategies. James Bradner is prompted to provide further details in response.

In the paragraph, Yaron discusses that there will be no interim data from Part 2 of an ongoing study, with results expected by the end of the year. The ADA presentation will cover mechanistic studies, Phase II and Phase I study details, and insights from key opinion leaders. Additionally, there is an interest in data supporting the transition of patients to MariTide from other weight loss medications. Umer Raffat then raises a question about market dynamics for UPLIZNA in the myasthenia gravis market, noting that competitor FcRn drugs might be priced higher due to dosing holidays as per the label, but many clinicians dose continuously. He inquires whether payers are aware of this and what market share UPLIZNA might realistically capture, given the potential pricing of competitors.

The paragraph is from an earnings call or an investor update where various executives are discussing UPLIZNA, a medication used in the GMG (Generalized Myasthenia Gravis) space. Robert Bradway invites comments from other executives like Jay and Murdo Gordon. James Bradner discusses UPLIZNA's favorable efficacy and target product profile, highlighting its significant results and advantages, such as steroid sparing and convenient dosing. Murdo Gordon comments on the pricing dynamics, suggesting that payer policies will likely ensure broad access to the treatment, potentially offering a cost advantage over other agents. The conversation then transitions to David Amsellem from Piper Sandler, asking a question about TEPEZZA.

Murdo Gordon addresses concerns about the growth of TEPEZZA by explaining that progress is being made in expanding its prescribing base beyond its initial audience, which primarily involved oculoplastic surgeons treating more severe cases. The strategy now involves engaging general ophthalmologists and endocrinologists to not only diagnose thyroid eye disease but also initiate treatment with this infused biologic. Although it's a gradual process due to the required steps like diagnosis, prescribing, navigating payer processes, and starting infusions, there is a positive trend with increased intent to prescribe among endocrinologists. This indicates potential for future growth, but significant changes in the product's trajectory will take time.

The paragraph discusses the progress of subcutaneous administration for a treatment, highlighting its potential to simplify care and expand patient treatment opportunities. It also touches on the international expansion of TEPEZZA, with recent approvals in Japan, Saudi Arabia, Brazil, and a positive opinion in Europe, indicating ahead-of-schedule progress. The text emphasizes the significance of the rare disease portfolio, including TEPEZZA, UPLIZNA, KRYSTEXXA, and TAVNEOS, as key growth products both domestically and internationally. Additionally, it mentions the closing of a transaction in October 2023 and the achievement of cost synergy and capital structure targets. Finally, the paragraph transitions to a Q&A session with Jay Olson from Oppenheimer.

The paragraph discusses the upcoming readout of the Bemarituzumab Phase III study, expected in the second quarter. Bemarituzumab is a fibroblast growth factor receptor IIb directed monoclonal antibody targeting gastric cancer cells. Two Phase III trials are being conducted: FORTITUDE 101, which is expected to improve overall survival in gastric cancer patients, and FORTITUDE 102, which combines Bemarituzumab with chemotherapy and nivolumab. The addressable population for Bemarituzumab is significant, given that gastric cancer is the fifth most common cancer worldwide. Over 1 million new cases occur globally each year, with about 25,000 in the U.S. The initial addressable patient population in the U.S. is roughly 7,000.

The paragraph discusses the potential and strategy for a KRAS franchise, particularly focusing on the AMG 410 asset. Murdo Gordon highlights the interesting aspects of AMG 410, a low molecular weight, orally bioavailable small molecule inhibitor of KRAS, which was recently showcased at the AACR. The conversation touches upon the competitive landscape of KRAS drugs and how AMG 410 fits into it. It also mentions the success of LUMYKRAS, which targets the G12C allele, noting the challenges in targeting other KRAS alleles due to the lack of a cysteine handle.

The paragraph discusses the development of a reversible pan-KRAS inhibitor targeting multiple KRAS mutations, with high selectivity over HRAS and NRAS, promising excellent tolerability and a strong therapeutic index. The medicine is in expedited development for solid tumors, both alone and in combination, as part of a Phase I/II clinical trial. The competitive KRAS therapeutic space includes the AMG 410 drug as a leading candidate. There is positive feedback from the KRAS community, despite challenges with other inhibitors. Additionally, a question about TEZSPIRE and its application in treating chronic rhinosinusitis with nasal polyps and its potential overlap with asthma patients is raised by Matt Phipps. Murdo Gordon acknowledges the opportunity for biologics in potentially advancing beyond surgery in the long term.

The paragraph discusses a medical condition affecting 1 to 2 million patients in the U.S., characterized by chronic sinusitis and nasal polyps, often overlapping with severe asthma. It highlights the efficacy of TEZSPIRE in reducing the need for surgery and improving patients' quality of life. The conversation then shifts to a question about the market prospects for rocatinlimab in the atopic dermatitis market. Murdo Gordon expresses optimism about rocatinlimab's potential, acknowledging the existing need for improved treatments in this space. However, he refrains from speculating on market share against other treatments still in development.

The paragraph expresses appreciation for the audience's interest and informs them that Justin and his team will be available for the rest of the day to answer any remaining questions. It highlights the excitement about the business's current momentum and future prospects, and concludes the Amgen Q1 FY 2025 Earnings Call, with a note that they look forward to future interactions later in the year.

This summary was generated with AI and may contain some inaccuracies.